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Quality Assurance Scientist for QC

Adecco A/S



  • Job reference 4255817429

The QA Operations team is expanding and is looking for an experienced QA scientist to assist with quality assurance of Quality Control (QC) activities for biological API and Drug Product for phase I-III clinical trials and commercial approved products in the US and EU.

QA Operations
QA Operations consists of highly qualified technicians and scientists with various professional backgrounds and several years of experience within Quality Assurance. Besides the QA Operations team, the quality unit department consist of the teams Quality Systems and QA Facility and Equipment. The main responsibility of the QA Operations team is quality assurance of manufacturing activities, batch release and QC documentation.

We are actively involved in the constant development within our field and the continuous improvement of our quality system. We aim at constantly ensuring that manufacturing and QC activities are in compliance with current standards for GMP production, i.e. EU GMP, 21 CFR and ICH guidelines.

The department has an open communication with focus on a high level of professionalism. We are open-minded and have a high service level to our colleagues in the rest of AGC Biologics A/S - and not least to our international customers. The QA Operations team is characterized by positive and proactive colleagues meeting deadlines through committed and friendly collaboration.

Tasks and Responsibilities
As QA Scientist you will be involved in various daily operational tasks in a dynamic and challenging environment. The team handles review and approval of QC documentation; review and approval of stability protocols and reports, analytical methods, validation protocols and reports. Approval of reference materials, assessing and approval of deviations, CAPAs, change control and OOS investigations.

You will contribute to the handling of mentioned team tasks, and a major part of the job will be on activities related to QC documentation and Quality Assurance guidance of QC. Also, you will be handling customer contact on QC related activities and participate in inspections and audits.

We cooperate closely with the other departments in the organization in order to ensure that all quality related activities are carried out effectively and in compliance with cGMP.

Your Profile
Preferably you have experience with Quality Assurance of QC. It is a requirement for this position to have a relevant academic background within pharmacy, biotechnology, biology or similar.
Ideally, you have experience within a number of the following areas:

  • Experience within quality assurance or quality control
  • Experience from the pharmaceutical industry
  • GMP requirements for quality control
  • Analytical method validation
  • Development of analytical methods
  • Professional presentation of quality in customer relations
  • Experience with Contract Manufacturing.

It is of utmost importance to have a self-motivating personality with a pragmatic attitude and approach to the daily work - without compromising quality. The environment is dynamic and challenging, which requires the ability to find solutions, deliver on promises and give our customers a positive experience.

AGC has international customers and our company language is English. It is therefore a required ability that communication in both written and spoken English is fluent.

AGC Offers
AGC offers a dynamic working place with good opportunities of working with a varied array of tasks and challenges. You will get insight into and experience with the way the various departments throughout a contract manufacturing organization interact in order to achieve success. Exciting and challenging assignments will constantly come your way, and you will to a large extend be able to plan your daily work yourself. AGC offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC’s employees have a flexible attitude and we help each other to reach deadlines together as one team.
Submit your CV, application, references and criminal as soon as possible. We treat the applications as we receive them, and conduct interviews with qualified candidates. When the right candidates are found, the add will close.

AGC Biologiscs is partnering with Adecco on this recruitment, so if you have any questions about the position, you can contact our recruitment team:

Line Sophie Heyn +45 3838 1211

About AGC Biologics
AGC Biologics (AGC) is a global Contract Manufacturing Organization (CMO) with biomanufacturing facilities in Europe, Japan and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.

AGC Biologics also offers non-exclusive license to CHEF1™, a proprietary CHO cell line development platform. CHEF1 delivers stable, high-titer, production-quality cell lines in optimized time frames. It is the foundation of AGC Biologics’ innovative approach to cell line and process development.

Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.

Om AGC Biologics

Kontaktoplysninger
Recruitment Team

+45 3838 1211

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Opslagstype
Fuldtidsjob
Geografi
Udlandet (øvrige)
Uddannelse
Kemi, Biotek & Materialer
Naturvidenskab
Arbejdsområde
Data & analyse
Forskning & Udvikling
Medicinal & Sundhed
Naturvidenskab
Produktion
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Åboulevarden 70. 2.
8000 Århus
Logo: Adecco A/S
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